Diagnostic, Prescriptive, And Data-Gathering System And Method For Macular Pigment Deficits And Other Eye Disorders

ABSTRACT

A macular health measurement and storage system comprises a plurality of macular-pigment measurement machine for measuring macular pigment density in humans, a plurality of computers each of which is associated with a corresponding one the macular-pigment measuring machines, and a central host. The plurality of macular-pigment measurement machines include a device for receiving macular pigment data from a patient, at least one data transfer port, and at least one processor that enables the transfer of the macular pigment data from the transfer port. The plurality of computers include a first port coupled to the data transfer port of the corresponding macular-pigment measurement machine for receiving the macular pigment data. Each of the computers includes a second port for transferring patient data. The central host is coupled to the second ports on each of the plurality of computers. The central host includes a storage device for storing the patient data.

FIELD OF THE INVENTION

This invention is in the fields of eye care, nutritional supplements,and diagnostic methods and systems, and relates to both: (i) acomputerized device that can be installed and used in a single location(e.g. a optometrist's office) for diagnosing abnormal macular pigmentlevels, which may eventually cause vision loss; and, (ii) a distributedcomputer system that links computers at many locations to a centralizedcomputer that compiles and analyzes data to create improved riskassessments and better prevention and intervention treatments.

BACKGROUND OF THE INVENTION

Nutritional supplements, which play important roles in preserving eyehealth, can be purchased “over-the-counter” (i.e., without requiring aprescription from a physician) and are usually taken in unit dosages.Nutritional supplements, which contain nutrients that occur naturally ina healthy diet, are very different from prescription drugs, which (inthe United States) can be sold only by pharmacies that require aprescription from a doctor. “Nutrients” are compounds that are oftenfound in a normal human diet and/or a healthy human body (this caninclude precursors, etc.), regardless of whether they are synthesizedchemically, or extracted from natural sources. The term “nutrients” isgenerally intended to be distinct from pharmaceuticals, antibiotics, andother “xenobiotic” compounds that are not normally found in naturalsources. “Unit dosage” forms comprise formulations designed to enable auser to know and control the quantity of a nutrient or nutritionalsupplement that is being ingested each day. Unit dosage formulationsinclude, for example, tablets and capsules (which includes hybrid-typepills, such as coated tablets, “caplets”, etc.), powders or liquids thatare accompanied by measuring and quantity instructions. However, thepresent invention can be useful if levels of a supplement exceedpredetermined levels such that the nutritional supplement is a“prescribed” nutritional supplement.

One problem associated with nutritional supplements relates to whetherthey assist each individual in preventing eye disorders or helping totreat eye disorders. Another problem is that some individuals have theperception that their diet is “acceptable,” when, in fact, it isdeficient in providing certain nutrients. As such, many individuals whomay benefit from nutritional supplements are often reluctant to usenutritional supplements. As such, what is needed is a system and methodthat allows individuals to easily understand the beneficial effects thatwill occur if the patient takes the nutritional supplement for a shortperiod of time, such as several weeks or several months (e.g., every 6months).

Nutritional supplements can provide (i) health-sustaining benefits, whenused as preventive (or prophylactic) agents by someone who is relativelyhealthy, and/or (ii) disease-treating benefits, when used as therapeutic(or treatment) agents by someone who is suffering from a known disorder(therapeutic use is often referred to also as drug use). The distinctionbetween preventive use versus therapeutic use depends on the status ofthe person being treated, and that status often falls into an unknown,“early onset”, or other borderline or boundary area where the propercategory is not always clear. It should also be recognized thatpreventive (prophylactic) use normally involves lower dosages, whiletherapeutic use usually involves higher dosages.

As discussed below, this invention relates to a computerized system thatenables front-line eye-specialists to become actively involved in anationwide and worldwide data-gathering system, that focuses upon (butis not limited to) measuring and analyzing macular pigment, which isimportant to preventing and treating a number of eye and visiondiseases, including macular degeneration. As used herein, a “front-lineeye specialist” includes any person (e.g., a heath care worker) who istrained and qualified to work with individuals to allow measurements tobe taken of the patient's eyes via the devices listed below. Thedefinition includes optometrists and other eye vision centers, that areoften the first and, in many cases, the only eye care specialists thatmost people will ever see. Front-line eye specialists also includehealth-care workers who work in hospitals and nursing homes in whichpatients are treated. Ophthalmologists, who are highly-trained eyespecialists, can also serve to provide “front line” eye care, and may beincluded as well.

As such, the role of front-line eye specialist in actually preventingeye diseases and blindness will become substantially greater becausethey will be in the ideal position to take the necessary “first steps”toward ensuring that their clients, customers, and patients beginreceiving and taking suitable nutritional supplements to help thoseclients, customers, and patients preserve their eyes and vision, as soonas possible, to minimize the extent of early and potentiallyirreversible loss and damage.

With the foregoing as preface, the remainder of the description belowfocuses on a group of retinal diseases that are collectively referred toas “retinal degeneration” and the use of nutritional supplements (inparticular, zeaxanthin and lutein) that will help prevent and treatpatients with the retinal degeneration. Retinal degeneration includesmacular degeneration and diabetic retinopathy.

The Retina, the Macula, and Macular Degeneration:

The retina is the layer of nerve cells at the back of the eye, whichconvert light into nerve signals that are sent to the brain. In humans,and in other primates (but not in most other mammals, or other types ofanimals), the retina has a small yellowish area in the center of thefield of vision. That yellowish area is called the “macula.” It providesfine-resolution vision in the center of the visual field, and it isessential to good vision. People who suffer from macular degenerationoften lose the ability to read, recognize faces, drive, or walk safelyon unfamiliar routes.

The surrounding portions of the retina can only provide coarseresolution. This physiological feature limits and controls the number ofnerve signals that the brain must rapidly process, to form coherentrapid-response vision, and it also helps limit and control the hugenumber of rod and cone receptors that the eye must continuallyregenerate and recycle, every day. Many people do not realize the retinacan provide only coarse resolution, outside of a limited central area,because the eyes and the brain have developed an extraordinary abilityto synthesize coherent vision from a combination of fine and coarseresolution. During that type of vision synthesis, the eye muscles causethe eyes to flit back and forth over a larger field of vision, pausingat each location for just an instant while the eye quickly “grabs” afine-resolution image of a limited area. This process occurs so rapidlythat a person doesn't notice it happening, and doesn't pay attention tohow a complete visual image and impression is being assembled andupdated from combinations of fine and coarse resolution images.

However, the steps and components that are involved in how vision iscreated, not just by the eyes but by the brain as well, can berecognized, if someone pays particular attention to various aspects ofit. As a simple demonstration, if someone focuses intently on a singleword, on a printed page, it is effectively impossible for that person toread any words that are only an inch above or below the word that isbeing focused upon, at the center of the field of vision. Similarly,someone who begins to suffer from “macular degeneration” will be forcedto realize how important fine resolution is, in human vision. That typeof fine resolution is provided only by the macula, and the macula coversonly the center portion of the field of vision.

There is also a peculiar anatomic structure in the retinas of humans,which points out the difference between fine resolution (provided by themacula) and coarse resolution (provided by the remainder of the retina).In humans, the blood vessels that serve the retina actually sit in frontof the retina, where they can block and interfere with incoming light,before the light reaches the retina. This is counter-intuitive, and oneshould wonder why the retina evolved with a physical handicap thatliterally gets in the way of good, clear vision. The answer is, in thoseparts of the retina, only coarse vision is being created, and bloodvessels positioned in front of the retina do not interfere with thattype of coarse vision. By contrast, in the macular region in the centerof the retina, the blood vessels are moved back, and positioned behindthe layer of neurons with rod and cone receptors. This is consistentwith the macula providing fine resolution vision, which would be blockedand hindered if the blood vessels were located in front of the neurons,in ways that would intercept and blocking portions of the incominglight.

“Retinal degeneration” is a descriptive term, which refers to andincludes an entire class of eye diseases and disorders. It includes anyprogressive disorder or disease that causes the macula to graduallydegenerate, to a point that substantially impairs or damages eyesightand vision. Several major categories of retinal degeneration are known.These include: (i) age-related macular degeneration, which graduallyappears among some people over the age of about 65; (ii) diabeticretinopathy, in which problems with sugar and energy metabolism damagethe entire retina, including the macula; (iii) eye diseases that affectthe macula due to gene and/or enzyme defects, such as Stargardt'sdisease, Best's disease, Batten's disease, Sjogren-Larsson syndrome, andvarious other eye disorders that lead to gradual degeneration of themacula (and possibly other parts of the retina) over a span of time.That is not an exclusive list, and other subclasses and categories alsoare known. For example, age-related macular degeneration is subdividedinto wet and dry forms, depending on whether abnormal and disruptiveblood vessel growth is occurring in the structural layers behind theretina.

The causes and effects of macular degeneration, and efforts to preventor treat it, are described in numerous books (e.g., “MacularDegeneration,” by Robert D'Amato et al (2000) and “Age-Related MacularDegeneration,” by Jennifer Lim (2002)), articles (“Age-Related MacularDegeneration” by Berger et al (1999)) and patents, such as U.S. Pat. No.Re. 38,009, which is assigned to ZeaVision LLC, and is incorporated byreference in its entirety.

In recent years, awareness has grown, among some researchers but notamong the general public, of the roles that macular pigment plays, inthe health and longevity of the macula. Therefore, the two carotenoidpigments that create and provide the macular pigment are discussedbelow.

The Macular Pigments: Zeaxanthin and Lutein:

The macula has a yellowish color because it contains unusually highconcentrations of two specific pigments, called zeaxanthin and lutein.Both are carotenoids, similar to beta-carotene but with hydroxy groupscoupled to their end rings (the presence of one or more oxygen atomscauses a carotenoid to be categorized as a “xanthophyll”, so zeaxanthinand lutein are sometimes referred to as xanthophylls). Both of those twocarotenoids are known to be protective and beneficial, in human retinas,by mechanisms that include: (1) absorption of destructive ultravioletphotons; and (2) quenching of destructive radicals. Both of thosemechanisms, and other potential protective mechanisms, are discussedbelow.

In addition to their involvement in the macula and macular degeneration,zeaxanthin and lutein also are present in other eye structures(including lenses), and undesirably low levels of those two carotenoidsappear to be correlated with higher risks of disorders such ascataracts. Accordingly, although the discussion herein focuses onmacular degeneration, it should be recognized that any comments hereinabout macular pigment levels also have varying degrees of relevance tosome other eye disorders as well. Similarly, any comments herein aboutmacular degeneration should be recognized as including disorders thatare referred to by other names (such as diabetic retinopathy,Stargardt's disease, etc.), but that involve or lead to gradualdeterioration of the macula.

The structures of zeaxanthin and lutein are shown in FIG. 1. They arevery similar, and are isomers of each other, differing only in theplacement of a double bond in one end ring, as indicated by the arrow inFIG. 1. In lutein, the ring with a “misplaced” double bond is called an“epsilon” ring. All of the other end rings shown in FIG. 1 have “beta”ring structures, which refers to the sequence of double bonds found inbeta-carotene's two end rings.

However, that single minor structural difference, between zeaxanthinversus lutein, has profound effects on the traits, performance, andtissue concentrations of those two different molecules, in both plantsand animals. Briefly, the lutein molecule has a bend where the epsilonring joins the “straight chain” segment between the two end rings. Thatbend, near one end, allows lutein to fit properly into ring-shaped“light-harvesting” structures, in the chloroplasts of plant cells. Sincelight-harvesting (which is part of photosynthesis) is crucial in plants,lutein evolved as a major and dominant carotenoid, in essentially allplants.

By contrast, zeaxanthin does not have a bend at either end. Since it isrelatively straight, it cannot fit properly into the circularlight-harvesting structures that help carry out photosynthesis, inplants. Therefore, it evolved in plants in ways that led to a verydifferent role in a day-night cycle, in which zeaxanthin and a similarcarotenoid called violaxanthin are converted back and forth into eachother. As a result, zeaxanthin does not accumulate in substantialquantities in most types of plants (although a few exceptions are known,such as corn and red peppers). Even in dark green plants, such asspinach or kale, lutein content is dozens or even hundreds of timesgreater than zeaxanthin content. On an aggregate basis, the total amountof zeaxanthin in typical diets in industrial nations is believed to beabout 1% (or possibly even less) of the total lutein supply.

Another major difference between them is that lutein can be obtained inbulk, and at low cost, from the orange flowers of marigolds. Since thatsource is available and inexpensive, lutein from marigolds has been usedfor decades as a major coloring pigment, in poultry and farm-raisedsalmon. In poultry, lutein causes the skin and yolks to turn yellow,which becomes a deeper golden tint when a red pigment is also added.That golden tint is appealing to consumers; without it, chicken meatthat is packaged and refrigerated for sale in a store tends to have apale, bleached, pasty appearance, and does not look fresh or appealing.In contrast, no comparable supplies of zeaxanthin in bulk have beenavailable, and the development and use of zeaxanthin lagged far behindlutein. It should be noted that the majority of currently availablesupplies of lutein contain relatively small quantities of zeaxanthin(e.g. about 5% or less). In fact, for a number of years, zeaxanthin wasregarded by some lutein sellers in their sales materials, as merely animpurity in their lutein. The first large-scale commercial sales ofconcentrated zeaxanthin, for ingestion by humans, did not begin until2002, when Roche Vitamins (subsequently purchased by DSM Chemicals)began selling a synthetic version, which was encapsulated and sold byvarious retailers, including ZeaVision LLC, the assignee herein.Ingestion of zeaxanthin by a human provides benefits to the macula.

Another important difference between zeaxanthin and lutein is thatzeaxanthin has a longer and more protective “conjugated cloud” ofelectrons surrounding it, compared to lutein. When a series of carbonatoms are bonded to each other by alternating double and single bonds,the electrons become mobile, and are no longer affixed to specific bondlocations. Those electrons form a flexible and movable electron “cloud”.This same type of cloud also appears in benzene rings and other“aromatic” organic compounds, and it is well-known to chemists.

That type of flexible and movable electron cloud is ideally suited forabsorbing high-energy radiation (in the ultraviolet, near-ultraviolet,and deep blue part of the spectrum), without suffering damage orbreakage of the molecule. In addition, a flexible and movable electroncloud is ideally suited for neutralizing and “quenching” oxygenradicals, which are aggressively unstable and destructive molecules,containing oxygen atoms having unpaired electrons. Oxidative radicalsare important damaging agents in any cells and tissues that are beingbombarded by high levels of UV radiation, since UV radiation oftenbreaks bonds that involve oxygen atoms, in ways that create unpairedelectrons where the broken bonds previously existed.

All carotenoids are assembled, in plants, from a 5-carbon precursorcalled isoprene, which has two double bonds separated by a single bond.As a result, all carotenoids have at least some sequence of alternatingdouble and single bonds, leading to a conjugated electron cloud coveringat least part of the carotenoid molecule. This is a basic and sharedtrait of all carotenoids, and it explains how carotenoids provide twocrucial benefits (i.e., absorption of UV radiation, and quenching ofdestructive radicals) that are vital to plants, which must often sit indirect sunlight for hours each day.

However, different carotenoids have conjugated electron clouds thatdifferent lengths, and different potencies and protective traits. Inparticular, there is a crucial difference between the conjugatedelectron clouds of zeaxanthin, and lutein. As shown in FIG. 1, theplacement of the double bonds in both of zeaxanthin's two end ringscontinues and extends the pattern of alternating double and singlebonds, from the straight chain. This extends zeaxanthin's conjugated andprotective electron cloud, out over a part of both of zeaxanthin's twoend rings.

By contrast, as shown in FIG. 1, the position of the double bond inlutein's “epsilon” ring disrupts the alternating double/single bondsequence, established by the straight-chain portion of the molecule.This disrupts and terminates the conjugated electron cloud, and itprevents the protective, UV-absorbing, radical-quenching electron cloudfrom covering any part of lutein's epsilon end ring.

That structural difference in their end rings becomes highly important,because zeaxanthin and lutein are deposited into animal cells in waysthat cause them to “span” or “straddle” the outer membranes of thecells. It causes zeaxanthin and lutein to be deposited into animal cellmembranes in a way that places them perpendicular to the surfaces of themembrane that surrounds and encloses a cell.

That “spanning” or “straddling” orientation, across the thickness of theouter membrane of an animal cell, arises from the presence of the two“hydrophilic” (water-seeking) hydroxy groups on the end rings of thosetwo carotenoids. On the other hand, Beta-carotene has no hydroxy groupson either end ring. Therefore, Beta-carotene settles into the oilyinterior layer of a cell membrane, effectively hidden from the wateryliquids that are both inside and outside of the cell. Beta-caroteneeventually is broken in half, by enzymes, to release two molecules ofretinol, which is Vitamin A. Nearly all carotenoids that are importantin animal health and physiology are derived from beta-carotene. It isnot just a coincidence that those carotenoids happen to have molecularlengths that allow them to extend a portion of both end rings, slightlybeyond the surface of an animal cell membrane.

The “membrane-spanning” orientation of zeaxanthin or lutein, in animalcells, causes portions of the end rings of both molecules to be exposedon the inner and outer surfaces of an animal cell membrane. One end ringwill be exposed to blood, lymph, and other “extracellular” fluidsoutside of the cell. The other end ring will be exposed to the wateryliquid inside the cell (often called the cytoplasm or cytosol).

The “membrane-spanning” positioning of zeaxanthin, in an animal cellmembrane, allows it to provide a protective electron cloud that extendsoutward from both the inner and outer surfaces of an animal cellmembrane. On that subject, it should also be noted that zeaxanthin iscompletely symmetric, end-to-end. Therefore, it makes no differencewhich end ring of zeaxanthin is “grabbed” by an enzyme that is preparingto insert the zeaxanthin molecule into an animal cell membrane.

By contrast, since lutein has no protective electron cloud over one ofits two end rings, it cannot provide a protective electron cloudextending from one of the two sides of an animal cell membrane.Furthermore, lutein is not symmetric, end-to-end, since its two endrings are different.

It is not fully known, at a molecular level, how lutein's lack ofsymmetry, and lack of a protective conjugated electron cloud over oneend ring, affect its deposition in cells in the human macula. Forexample, it is not known whether the protective beta rings at one end oflutein are consistently or predominantly placed on the either theexternal or internal surfaces of cell membranes. In addition, it is notknown whether lutein is consistently deposited, into human cellmembranes, in a membrane-spanning orientation.

However, other aspects of zeaxanthin and lutein content and depositionin blood, and in the macular regions of human retinas, are well-known.Despite the rarity of zeaxanthin in food sources (as mentioned above,zeaxanthin content in typical diets is believed to be less than about 1%of the lutein supply), zeaxanthin concentrations in human blood averageabout 20% of lutein levels. This clearly indicates that the human bodydoes something that indicates a selective preference for zeaxanthin,over lutein.

Even more revealingly, zeaxanthin is even more concentrated in thecrucially important center of the human macula, which providesfine-resolution vision in humans. In the crucially important center of ahealthy human macula, zeaxanthin is present at levels that average morethan twice the concentrations of lutein. By contrast, lutein is presentin higher levels around the less-important periphery of the macula.While the mechanisms which create that pattern of deposition are notfully understood, it recently has been reported that certain enzymesthat appear to be involved will clearly bind to zeaxanthin withrelatively high affinity under in vitro conditions; however, those sameenzymes will not bind to lutein with any substantial affinity (Bhosaleet al 2004).

Accordingly, these differences in how zeaxanthin and lutein aredeposited in the macula provide strong evidence that the macula wantsand needs zeaxanthin, more than lutein. The patterns of deposition, andthe known structural and electron cloud differences, suggest andindicate that the macula wants and needs zeaxanthin, and it uses luteinonly if and when it cannot get enough zeaxanthin.

This belief is also supported by another important finding. The maculamay attempt to convert lutein into zeaxanthin. However, the conversionprocess cannot convert lutein into the normal stereoisomer of zeaxanthinfound in plants and in the diet (the 3R,3′R stereoisomer). Instead, itconverts lutein into a different stereoisomer that has never been foundin any food sources or mammalian blood. That non-dietary isomer has oneend ring with the conventional “R” configuration; however, the secondend ring has an unnatural “S” configuration that is never found in thenormal diet. That S—R isomer (and R—S isomer) is called meso-zeaxanthin,which is also shown in FIG. 1. It is included herein as a subset ofzeaxanthin, and the machines and methods disclosed herein can be used,if desired to evaluate any benefits it may offer, in human use, althoughthe preference is for the naturally occurring isomer of zeaxanthin.

Consequently, while lutein may have benefits, a growing body ofknowledge and evidence indicates that zeaxanthin is the ideal carotenoidfor helping prevent and treat the class of eye diseases that fall intothe category of macular degeneration.

In light of the previous information concerning the macula and themacular pigments, this invention creates a computerized network andmachines that accomplish one or more of the following functions:

(i) enable all practicing front-line specialists, such as optometrists,to rapidly diagnose the main etiologic factor that appears to cause mostcases of macular degeneration (i.e., a vitamin deficiency involving lowlevels of the protective carotenoid, zeaxanthin), even at the veryearliest stages of the disorder, which can be years before thenoticeable symptoms of failing eyesight begin to trouble a patient;

(ii) provide front-line specialists with better, more convenient andaffordable tools for measuring and diagnosing macular pigment levels inpatients;

(iii) establish an improved but widespread and proper standard of carein ways that will greatly reduce the actual rates and risks of blindnesscaused by AMD;

(iv) rapidly provide much better, much more useful, and much less costlydata for analysis;

(v) enable numerous front-line specialist to begin contributing usefuldata involving small numbers of patients from each practice, in a waythat rapidly amounts to large numbers of patients in the aggregate,comparing various eye supplements (e.g., zeaxanthin v. lutein v.zeaxanthin-lutein mixtures) for actual efficacy in either preventing ortreating macular degeneration;

(vi) creating a computerized network that has data-gathering anddata-processing capability, which can continuously and rapidly compile,process, digest, and report large numbers of data concerning maculardegeneration and efforts to treat or prevent macular degeneration,including data that will be generated in one or more multi-site,nationwide, and/or worldwide meta-trials involving intervention studies,including but not limited to intervention studies that includeadministration of zeaxanthin, lutein, or zeaxanthin-lutein mixtures(either with or without additional nutrient supplements, drugtreatments, etc.) to people who are suffering from, or who are atelevated risk of, macular degeneration.

The invention also relates to a business method that utilizes acombination of computers, computer software, and computerized peripheraldevices to enable better and more efficient prevention of vision lossand blindness, by means of low-cost systems in front-line specialists'offices. With relatively low training and operating requirements, thesedistributed computerized systems will be designed to provide two majorsets of benefits. First, when dealing with specific patients, thissystem will enable front-line specialists to gather useful dataconcerning macular pigment levels, in any customer or patient, andrapidly provide, to any patient in need of such treatment, a nutritionalsupplement that can raise his or her macular pigment levels. Second, andwithout interfering with the goal of serving individual patients, thiscomputerized business process described above will also enable thegathering and analysis of highly useful statistical data from thousandsof patients by means of a “meta-trial” approach, in which each ofhundreds or thousands of participating front-line specialists willcontribute de-identified data from dozens of patents, rapidly leading tovery large populations and reliable statistical analyses. This type ofmeta-trial testing using the computerized system disclosed herein canprovide, for example, rapid and reliable data from human trials thatwill enable direct comparison of the actual contributions and benefitsof zeaxanthin supplements, lutein supplements, or zeaxanthin-plus-luteinmixtures. As another example, this type of meta-trial testing using thecomputerized system disclosed herein can enable the testing andevaluation of multiple differing combinations of various known candidateactive ocular agents, in ways that will help researchers develop abetter understanding of which combinations of such agents will providethe most benefits, either for all patients, or for specific categoriesof patients.

Devices exist that measure a patient's macular pigment density. And, atleast one attempt has been made to allow patients to test their macularpigment density and send the test information to a remote site, asdescribed in “Validated Vision Test Battery for the Home PC” by Dagnelieet al (2002). However, the reliance on the video display of a homepersonal computer presents a high risk of error, especially when tryingto correlate results for individuals having substantially differenttypes of video displays. Further, there was no attempt to modulate oralter recommended nutritional supplements based on the data beingcollected by within a system. Hence, as described below, the presentinvention presents numerous substantial improvements to any such homePC-based type of system.

Large, cumbersome, and expensive multi-year government-run studies (suchas the AREDS-1 trial done in the 1990's and reported over the 2001-2005period, and the proposed AREDS-2 trial which has not even started yet,despite years of planning) take many years (perhaps a decade) togenerate useful results. Even more importantly, despite having years todo their work and budgets of tens of millions of dollars for each study,they have been criticized as being not being able to organize and runenough different treatment arms to adequately determine or evaluate thebest actual treatments.

The invention will become more apparent through the following summary,drawings, and description.

SUMMARY OF THE INVENTION

A computerized system comprises at least one hardware device thatfunctions as a “computer peripheral” device. This device measures thepatient's “macular pigment optical density” (MPOD). The devicepreferably transfers the MPOD data to a conventional desktop, laptop, orother computer, preferably via a standard port, such as a “universalserial bus” (USB) port and cable. In other embodiments, the MPOD devicemay include keyboards or touch-keys for input and a display for output,allowing for the removal of the computer in the system.

Various types of devices and methods for measuring MPOD are known,including “flicker photometer” systems that are relatively compact,inexpensive, and well-suited for placement and operation in any office,store, or other facility run by an optometrist. Such flicker photometerdevices also can be emplaced and operated in the offices ofophthalmologists, teaching hospitals, eye care centers, etc., and inlocations that also provide and operate more expensive and elaborateMPOD measuring systems. By using data from such locations, the ongoingperformance of the flicker photometer devices can be evaluated, bycomparing their results against data gathered by more elaborate andexpensive systems.

On a periodic basis (such as once per week, month, or quarter), thecomputer at each participating front-line eye-specialist office cantransfer a set of collated and processed data on MPOD readings(correlated with, for each patient, other aspects of eye health that theoptometrist deemed to be relevant and worth noting and recording) to ahost for gathering and processing the data from computers operated bynumerous locations. Such data transfers can be made via websites orother suitable linkage or transfer modes, and can be made duringlate-night or other low-traffic hours, in an automated manner controlledby specialized software that will be operating at each end to enableeach computer at an office to interact in a secure yet automated mannerwith the host. All such data gathering and transfer processes will bemade in ways that fully comply with all relevant laws governing theprivacy and use of medical records and informed consent by patients.

As part of the front-line eye-specialists' service for their patients,participating front-line eye-specialist will also gather and recordinformation on the eye and vision health (or level of impairment) ofeach customer or patient. This can include, for example, informationreported by clients on their medical history and status, informationgathered by an optometrist during a personal examination, andinformation gathered by various “computer peripheral” devices that canbe coupled to the optometrist's computer (such as, for example, data onlight sensitivity, dark adaptation, shape discrimination, peripheralsensitivity in the visual field, etc., all of which can be gathered viacomputerized peripheral devices while a patient is waiting to be seen byan optometrist). Alternately or additionally, multi-functionalcomputerized measuring devices can be created by additional componentsto an MPOD measuring device as described herein, and suchmulti-functional computerized devices can transfer all relevant data tothe computer in a single transfer.

Depending on a patient's choices and preferences, such data can becompiled and correlated in any of various ways, such as by correlatingall relevant information on macular pigment and eye health with: (i) apatient's full name; (ii) a patient's initials; or, (iii) an arbitrarycode number (de-identified data) that is assigned to a patient by theoptometrist, known only to the optometrist and transferred to the hostso that the patient remains anonymous.

This distributed computer and peripheral system will enable trainedeye-care professionals to determine and deliver truly effectiveprevention and treatment methods and regimens that can and will preventcases of preventable blindness. It also will enable patients toparticipate, in a convenient and inexpensive way that can be satisfiedwith an occasional visit to any nearby office in a well-designed,well-controlled, large-scale system that can greatly advance the abilityof eye care professionals to generate useful data from multiplepatients, and to transfer that data rapidly and efficiently into acomputerized system that can process and analyze the data, enabling dataprocessing specialists to rapidly identify trends and correlations. Italso can greatly advance the ability of eye care professionals torapidly and efficiently generate useful data from large-scale multi-siteintervention trials involving large patient populations, to evaluate theresults and effects of various candidate treatment regimens. Suchcandidate treatment regimens can involve, for example:

(i) direct comparison of zeaxanthin-only supplements against luteinsupplements (and against zeaxanthin-plus-lutein mixtures), forincreasing macular pigment density, and for improving other aspects ofoverall eye health;

(ii) administration of various candidate agents in combinations that maybe proven to have synergistic effects when combined in suitable dosages.Such combinations include, for example, zeaxanthin or possibly luteinsupplements (which are regarded as the essential core of any regimen forincreasing the benefits provided by the anti-oxidant and UV-absorbingmacular pigment) with additional regimens of one or more of thefollowing: Vitamins C and/or E, zinc, selenium, omega-3 fatty acids suchas docosa-hexaenoic acid (DHA), carotenoids such as beta-carotene,lycopene, and/or beta-cryptoxanthin, lipoic acid, taurine, carnitine,mitochondrial booster or stabilizer agents such as glutathione, N-acetylcysteine, or Coenzyme Q10, and plant-derived extracts or agents, such asbilberry extract, isoflavones or flavonoids from soybeans or otherplants, resveratrol, etc.

By contrast, a distributed computer network with supporting software andperipheral devices, placed in the offices of hundreds of eye careprofessionals who are already serving thousands of patients, will enablethe rapid gathering and processing of highly useful data that will servenumerous useful functions, including: (i) correlating macular pigmentdata with other aspects of eye health; (ii) enabling eye careprofessionals to administer and test macular-pigment enhancing formulaswith numerous other candidate active agents, in ways that can rapidlygenerate statistically significant and useful data on additive and/orsynergistic effects of numerous different combinations and regimens; and(iii) enabling the evaluation and compilation of statistical data onother types of eye and vision tests that may turn out to be usefulindicators or predictors of eye or vision problems among the elderly.

As such, the invention can be considered a macular health measurementand storage system that comprises a plurality of macular-pigmentmeasurement machine for measuring macular pigment density in humans, aplurality of computers each of which is associated with a correspondingone of the plurality of macular-pigment measuring machines, and acentral host. The plurality of macular-pigment measurement machinesinclude a device for receiving macular pigment data from a patient, atleast one data transfer port, and at least one processor that enablesthe transfer of the macular pigment data from the transfer port. Theplurality of computers include a first port coupled to the data transferport of the corresponding macular-pigment measurement machine forreceiving the macular pigment data. Each of the computers includes asecond port for transferring patient data. The central host is coupledto the second ports on each of the plurality of computers. The centralhost includes a storage device for storing the patient data.

The invention can also be considered a method of addressing visionproblems in individual human, comprising the act of obtaininginformation from patients at multiple locations, wherein the informationincludes macular pigment data obtained via macular-pigment measurementmachines at the locations. The macular-pigment measurement machines arelinked to a central host. In response to a patient lacking a desirablelevel of macular pigment, the method further includes providing thepatient with a recommendation for a first daily dosage of zeaxanthin (orother macular-pigment enhancing formulas) to increase macular pigment tothe desirable level over a period of time. In response to a patienthaving a desirable level of macular pigment, the method includesproviding the patient with a recommendation for a second daily dosage ofzeaxanthin (or other macular-pigment enhancing formulas) that is lessthan the first daily dosage. The method also includes periodicallytransferring the information to the central host from the plurality oflocations.

The method can also be considered a method of addressing vision problemsin humans, comprising the acts of obtaining information from patients atmultiple locations over a period of time, wherein the informationincludes macular pigment data obtained via a macular-pigment measurementmachine at the locations. The plurality of macular-pigment measurementmachines are linked to a central host and the information also includesspecific patient information allowing patients to be placed in aplurality of subgroups of an overall population of patients. The methodincludes storing the information at the central host and, after theobtaining and storing, identifying a first patient at one of themultiple locations as being a member of a first one of the plurality ofsubgroups. The method includes retrieving, from the central host,macular-pigment-density data corresponding to the first one of theplurality of subgroups and displaying the displayable information to thefirst patient at the one of the multiple locations.

The present invention also includes a method of addressing visionproblems in a population of humans. The method comprises the acts ofobtaining information from patients at multiple locations, wherein theinformation includes macular pigment data obtained via a macular-pigmentmeasurement machine at the multiple locations. The plurality ofmacular-pigment measurement machines are linked to a central host. Themethod further includes transmitting the information from the multiplelocations to a central storage device associated with the central host,and on a periodic basis (e.g., not more than one month, one week, oreven on day) transmitting specific sets of analyzed data from thepopulation to the multiple locations. Alternatively, the transmitting ofspecific sets of analyzed data to a certain location may be simply inresponse to a request made from that certain location.

The present invention also includes a method of conducting a study thatanalyzes an existing recommendation for eye health. The methodcomprising the acts of obtaining information from patients at multiplelocations, wherein the information includes eye-health data obtained viameasurement machines at the multiple locations. The method includeselectronically transferring the information to a central host that islinked to the multiple locations, and analyzing the information at thecentral host to develop a modified recommendation that modifies theexisting recommendation. Finally, the method includes transmitting themodified recommendation to the multiple locations. As one example, themodified recommendation may be an intake of a certain macular-pigmentenhancing formula to be recommended to the entire population or asub-group of the population.

The present invention can also be considered an eye health measurementand storage system. The system comprises a plurality of macular-functionmeasurement machines and a central host. The plurality ofmacular-function measurement machines measure macular function inhumans. Each of the macular-function measuring machines includes adevice for receiving macular function data from a patient, at least onedata transfer port, and at least one processor that enables the transferof the macular function data from the transfer port. The central host iscoupled to the transfer ports on each of the plurality of computers. Thecentral host includes a processor adapted to (i) store the patient datain a storage device and (ii) transmit macular-function study data totest locations associated with the plurality of macular-functionmeasurement machines.

Additional aspects of the invention will be apparent to those ofordinary skill in the art in view of the detailed description of variousembodiments, which is made with reference to the drawings, a briefdescription of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the chemical structures of zeaxanthin and lutein(with an arrow pointing out the misplaced non-conjugated double bond inone end ring of lutein), and beta-carotene (a similar carotenoid thatdoes not contain any oxygen molecules or hydroxy groups).

FIG. 2 illustrates an eye-health data gathering system.

FIG. 3 schematically illustrates a computer used in the eye-health datagathering system of FIG. 2.

FIG. 4 illustrates a display associated with the computer of FIG. 3 forinquiring information from a patient.

FIG. 5 illustrates a display associated with the computer of FIG. 3 forconfirming the results of an MPOD test.

FIG. 6 illustrates a display associated with the computer of FIG. 3 forconfirming, at a later date, information from the patient specified inFIGS. 4-5.

FIG. 7 illustrates a display associated with the computer of FIG. 3 forconfirming the results of an MPOD test taken at a later date.

FIG. 8 illustrates a display associated with the computer of FIG. 3 forgraphically describing the patient's MPOD test results.

FIG. 9 illustrates a display associated with the computer of FIG. 3 forconfirming the type of daily eye vitamins the patient is taking.

FIG. 10 illustrates a display associated with the computer of FIG. 3 forconfirming the results of an MPOD tests for a group of patients.

FIG. 11 illustrates a display associated with the computer of FIG. 3 forconfirming the results of an MPOD tests for a group of patients.

FIG. 12 illustrates one type of business method of using the system ofFIG. 2 to directly provide nutritional supplements, such asmacular-pigment enhancing formulas, from the marketer of suchnutritional supplements.

DETAILED DESCRIPTION

While this invention is susceptible of embodiment in many differentforms, there is shown in the drawings and will herein be described indetail preferred embodiments of the invention with the understandingthat the present disclosure is to be considered as an exemplification ofthe principles of the invention and is not intended to limit the broadaspect of the invention to the embodiments illustrated. As summarizedabove, this invention discloses and utilizes a distributed computerizedsystem, and a business method that uses and depends upon thecomputerized system.

The distributed computerized system comprises hardware and softwarecombinations that eventually will be installed in numerous (perhapsthousands) locations across the nation and around the world. The primarylocations for such installations will be the “front line” eye careoffices, such as where optometrists work, at other readily accessiblelocations such as shopping malls, retirement homes, etc., and at eventssuch as fairs, conferences, meetings, etc. Such “front line” eye carespecialists are the first (and often the only) eye care specialists mostpeople will ever see. The distributed computerized system allows formacular pigment measurements to be taken quickly and with little efforton the part of the patient. The data is useful for many reasons, such asallowing the specific patient to determine the effects of certainnutritional supplements, and allowing the collection and analysis ofdata for a large scale population.

Referring to FIG. 2, the system 10 includes a host 12 that has a centralprocessor 13 and a central storage device 14. The host 12 also includesa host interface 15 in which a host operator or analyst is permitted toreview information that has been collected by the host 12, analyze theinformation, or send specific information throughout the system 10.Preferably, the host 12 included data-processing software 16 forallowing the host operator at the host interface 15 to access the datain the storage device 14 and analyze the data. The host operator canalso make certain “packets” of data derived from data-processingsoftware 16 available throughout the system 10 so that the patients andfront-line eye specialists have access to important information,allowing them to understand the collected data regarding the eye studywithin the system 10 and to help them make important decisions for thepatient. One example of a data packet focused on a certain sub-group ofthe population is show below in FIGS. 10-11.

The host 12 is coupled to a plurality of remotely locatedmacular-pigment-measurement modules 18, each of which includes acomputer 20 and a MPOD device 22 for measuring macular pigment densityin a patient. It is contemplated that the system 10 will includemacular-pigment-measurement modules 18 a, 18 b, 18 c, . . . 18 n, whenthe number “n” is preferably very large, such as in the hundreds orthousands.

Within each macular-pigment-measurement module 18, the MPOD device 22 isused to measure the patient's macular pigment density through one ormore techniques, as described below. Each computer 20 is used forinterfacing with the patient, a local operator, and/or a front lineeye-specialist. Each computer 20 is additionally used to interface withthe host 12 and pass information to and from the host 12. As oneexample, information that is sent from the computer 20 to the host 12may include patient information, including macular pigment densities. Asanother example, information being sent from the host 12 to the computer20 may include data about a patient that was input at a differentlocation, but stored in the storage device 14, or statistical analysisof which eye supplements have been efficacious (for all patients orsubgroups of patients) based on large scale data collected by the host12 and analyzed by the storage device 14. More details of this type ofdata transfer will be discussed below, especially with respect to FIGS.4-11.

In one preferred embodiment, the host 12 conducts a data-compilingfunction that uses the Internet or other means to gather and compile,from the numerous computers 20, the data that has been gathered by thefront-line eye specialists and patients. The relevant data preferablyshould include: (i) pre-treatment data, such as age, gender, baselinemacular pigment density levels, eye and health status, any history ofsmoking, diabetes, or other relevant medical issues, etc.; (ii) data onany zeaxanthin and/or lutein supplements or other eye supplements thatare have been previously taken or have been prescribed, recommended, orsold to the patient; (iii) any changes in macular pigment levels thatare detected by retesting, over a span of time after supplement usagehas commenced; and, (iv) epidemiological data that tracks thedevelopment of macular degeneration, cataracts, changes in visualclarity, and other eye changes or disorders over a span of time. Inaddition, the business method that centers around the system 10 involvessteps and incentives (such as described below) to encourage front-lineeye specialists and their customers to participate in the process.

The host 12 includes a centralized processor 13 with appropriatestatistical or other analytical software, that processes and analyzesall of the data that have been gathered from numerous modules 18 in waysthat will reveal trends and results from various supplement treatments,in various categories of patients. This will allow analysts at the hostinterface 15 to determine “best practice” recommendations for variouscategories of patients. It will also enable analysts to continuallymonitor additional data that are being gathered, thereby enabling“feedback” that is continually or periodically being sent to the modules18 that will lead to refined and improved “best practice”recommendations for differing categories of patients. The feedback willinclude data “packets” derived from data-processing software 16, anexample of which is shown in FIGS. 10-11.

There are various types of MPOD devices 22 that could be used in thesystem 10 of FIG. 1. Seven different general groups of exemplary MPODdevices 22 will be discussed—(i) scanning laser ophthalmoscopy, (ii)reflectometry, (iii) “flicker photometry” (also known as“heterochromatic flicker photometry”, or HFP) (iv) autofluorescencespectrometry, (v) Raman scattering, (vi) modified fundas cameraphotography, and (vii) anomalscope. Each of these MPOD devices 22 can becoupled to the associated computer 20 and provide information concerningthe patient's macular pigment density. Each of these MPOD devices 22 hasits own combination of costs, convenience, accuracy, and drawbacksUnlike “post-autopsy” methods for chemically analyzing retinal tissuethat has been removed from the eye of a corpse, these non-invasivemethods of the MPOD devices 22 use light, photography, or similar means.The results usually are expressed as “optical density”, rather than asconcentrations. The acronym “MPOD” is often used, to represent “macularpigment optical density.” It is a dimensionless number, sometimesexpressed in terms of “density units.” With regard to Raman Scatteringin particular, its results are expressed in the form of Raman Counts,which is not a dimensionless number.

To provide a frame of reference, at the current time, various publishedarticles tend to suggest that MPOD values, as measured by flickerphotometry, of about 0.4 or higher tend to be reassuring, while MPODvalues less than about 0.3 (and even more especially, less than about0.2) tend to indicate a below-normal amount of macular pigment. However,those numbers have not yet reached a level of consensus acceptance, andquestions arise about how measurements made by different methodsactually compare against each other. As such, whichever type of MPODdevices 22 are used within the system 10, the outputs are preferablycalibrated so as to provide a consistent level of results over time.Depending on the method used, the MPOD values of what is “normal” may bedifferent, and the present invention assumes the MPOD devices 22 haveundergone calibration to develop a value of what is “normal,”“above-normal,” and “below-normal.”

These methods and machines are surveyed in “In vivo Assessment ofRetinal Carotenoids: Macular Pigment Detection Techniques and TheirImpact on Monitoring Pigment Status,” by Celentano et al (2002), areview that provides numerous citations to articles describing each ofthe main classes of machines. Other articles, such as “Influence ofLutein Supplementation on Macular Pigment, Assessed With Two ObjectiveTechniques” by Berendschot et al (2000), and “Macular Pigment DensityMeasured By Autofluorescence Spectrometry: Comparison with Reflectometryand Heterochromatic Flicker Photometry,” by Delori et al (2001), comparethe accuracy of various techniques against each other. These threearticles are incorporated by reference in their entireties.

Scanning Laser Ophthalmoscope (SLO)

A method called “scanning laser ophthalmoscopy” (SLO) is a somewhatcomplex and expensive MPOD device 22, and may require a highly trainedoperator. Briefly, SLO uses two different lasers to create two differentdigitized photographs of the macula, in two different “passes.” Onelaser uses a blue or blue-green wavelength, which is efficientlyabsorbed by the macular pigment. The extensive absorption of theblue-green light by the macular pigment leads to low levels of lightbeing reflected and emitted by the macular tissue, in ways that willcause the emitted light to reach a specialized camera that is positioneddirectly in front of the eye. The other laser uses a different color(such as red) that is not absorbed by the macular pigment.Non-absorbance of laser light having this color, by macular pigment,leads to higher levels of reflected and emitted light reaching thecamera. Both of those two lasers, with differing wavelengths, are usedto create digitized photographs called “macular pigment maps”. Aprocessor is then used to compare the two digitized maps against eachother. Large differences between the two maps indicate highconcentrations of macular pigment; smaller differences indicate lowerlevels of pigment.

Berendschot's “Influence of Lutein Supplementation on Macular Pigment,Assessed With Two Objective Techniques” (2000), which is hereinincorporated by reference in its entirety, indicated that over thecourse of time, when subjects participating in a lutein supplement trialwere analyzed repeatedly by SLO measurements, the “spread” or “scatter”of the data indicated that SLO was accurate to a level of about ±10% ofthe value indicated by a measurement. That was the highest level ofaccuracy that could be achieved by any of the MPOD machines that weretested by Berendschot et al (1999 & 2000). However, at the current time,SLO machines are fairly expensive and complex, which may make their usea bit more difficult for populating the offices of hundreds offront-line eye specialists. SLO machines and methods are described inmore detail in articles, such as Elsner et al 1998, which is hereinincorporated by reference in its entirety.

Reflectometry.

Another approach to measuring MPOD levels is usually called“reflectometry”. This type of MPOD machine 22 also uses at least twodifferent excitatory lights having two different wavelengths.

Some forms of reflectometry use two different wavelengths, which willinclude (i) a blue or blue-green wavelength that is absorbed by macularpigment, and (ii) a red or other wavelength that is not absorbed bymacular pigment. Other forms of reflectometry (usually called “spectral”reflectance) can measure a retinal reflection levels over an entirerange or spectrum of wavelengths, in a way that generates a curve whichdepicts the results across the entire spectrum.

In either case, a light beam with a known intensity is directed into theeye, and the intensity of any light that is reflected by the retina, andthat emerges from the eye and reaches a photodetector, is measured.Instead of creating a map or photograph, this analysis merely creates anumber for each wavelength that is measured. This number is usuallyexpressed as a ratio, in which the amount of light reflected back fromthe retina is divided by either: (i) the total amount of light that wassent into the eye, or (ii) the amount of light that was absorbed insidethe eye, calculated by subtracting the amount of emerging light, fromthe amount of light sent in. The number that corresponds to a red orother non-absorbed wavelength establishes a “baseline physiology” levelfor an eye, which can vary, depending on factors such as lens density,age and condition of the retinal tissue, etc. The number thatcorresponds to a pigment-absorbed blue or blue-green wavelength is thencompared against the number for the non-absorbed wavelength. Thisgenerates a numerical indicator of the macular pigment density in thateye.

Continuing the comparative analysis mentioned above, Berendschot et al(1999 2000) reported that in their lutein supplement trial, datagenerated by spectral reflectance indicated that their reflectometrymeasurements were accurate to a level of about ±17% of the valueindicated by a measurement (which was less accurate than the resultsobtained by the SLO method).

One promising reflectometry machine has been developed by a group (Dirkvan Norren, Jan van de Kraats, Suze Valen, & Tos T. J. M. Berendschot)at the University Eye Clinic Maastricht in the Netherlands. In a posterboard presentation at a meeting for The Association for Research inVision and Ophthalmology (ARVO) in April 2005 in Fort Lauderdale, Fla.,entitled “Fast and Objective Measurement of Macular Pigment with NaturalPupil,” (incorporated by reference in its entirety), the developersdescribe a reflectometry MPOD machine 22 that does not require eyedilation. The written form of the presentation is incorporated byreference in its entirety.

Flicker Photometry

A third method of determining MPOD values is usually called “flickerphotometry” (also known as “heterochromatic flicker photometry”, orHFP). It is sometimes called a “psycho-physical” method, since a personbeing tested must indicate when he sees, perceives, interprets, andbelieves something has happened. Various types of flicker photometershave been developed, and are described in U.S. Pat. No. 5,936,727 (Boneet al), U.S. Pat. No. 6,017,122 (Bone et al), and U.S. Pat. No.6,315,412 (Snodderly et al), and in articles such as “A Practical Methodof Measuring Macular Pigment Optical Density,” by Wooten et al (1999),“A Portable Instrument for Measuring Macular Pigment with CentralFixation,” by Mellerio et al (2002), and “Macular Pigment Measurement byHeterochromatic Flicker Photometry in Older Subjects: The Carotenoidsand Age-Related Eye Disease Study,” by Snodderly et al (2004). Thesepatents and articles are incorporated by reference in their entireties.

In this type of MPOD device 22, electrical and/or mechanical componentscan be used to create “pulsatile” light patterns that alternate back andforth between a blue color, and a green color. In one design that useselectronic means, a flicker photometer tightly packs together a numberof “light-emitting diodes” (LED's) in a small cluster. Some MPOD devices22 involving flicker photometer use a single small circle (such as lessthan about 5 mm or ¼ inch in diameter), while other machines use moreelaborate patterns (for example, Snodderly et al 2004 appears todescribe a circular cluster surrounded by an annular cluster, fordeveloping a “spatial profile”). LED's can respond very rapidly (such ashundreds or thousands of times per second) to changes in current passingthrough them. Some of the LED's in the cluster will emit light at a blueor blue-green wavelength that is absorbed by macular pigment, whileother LED's in the cluster will emit light at a different wavelength(usually in a green or green-yellow range) that is not absorbed as wellby macular pigment. Using an electronic circuit, the two different setsof LED's can be excited (“lit up”) in a manner that causes their lightemissions to alternate back and forth between the two colors, at afrequency that usually can be varied, but that typically alternates backand forth between two different profiles (or levels, conditions, etc.),over a range of about 10 to about 50 pulses per second.

A different design, disclosed in U.S. Pat. Nos. 5,936,727 and 6,017,122(Bone et al), uses a rotating mechanical plate or similar device, withan opening (which can be called a shutter, aperture, etc.) that passesover both a blue and a green light source, in a way that allows onecolor or the other to pass through the aperture. The speed of rotationof the shutter plate can be varied, causing the frequency of the lightpulses to vary. Flicker photometers that are believed to embody thisdesign are being offered for sale by a company called Macuscope(www.macuscope.com).

Regardless of which design is used, if the frequency of the pulsation isset at a high rate (such as about 50 cycles per second, or “hertz” (hz))and a suitable intensity, the macular pigment will absorb the blue lightin ways that prevent a viewer from detecting any noticeable “flickering”(or pulsating, etc.) appearance, in the light emissions having twodifferent colors. A rapid pulsating frequency prevents the macula fromdistinguishing between the two different colors, causing a rapidlypulsating light source to have a steady appearance.

However, because of certain aspects of photoreceptor physiology andchemistry, when the frequency of the pulsating color changes is reducedin a gradual and controllable manner, a threshold level will be reachedwhere the viewer notices that the light begins to appear unsteady, in aflickering manner. Alternately, if the frequency of the pulses is heldat a suitable rate (such as about 15 hz, for most people), but theintensity of one or both of the light emissions is gradually increased,a threshold level will be reached where the viewer notices that thelight begins to flicker.

When the threshold or transition stage is reached, during a slow andgradual ramping-type change of the frequency and/or intensity of thepulsatile light emissions, the viewer will take some action to indicatethat his or her threshold level has been reached. For example, in somemachines, the viewer can turn a knob that adjusts the frequency orintensity of the pulsating blue and green light emissions, until theflicker disappears and the blue-green dot appears steady and constant.In other machines, the viewer can press a button as soon as he or shenotices that the colored dot has begun to flicker.

Regardless of which type of action is taken by the user, the frequency,intensity, or other gradually changing trait of the electrical pulsesthat are being sent to the diodes, at that threshold level, will beprocessed or recorded by the machine.

Since higher concentrations of macular pigment lead to higher absorptionof blue light, a lower sensitivity to a flickering appearance iscorrelated with higher macular pigment concentrations. As a result,flicker photometry machines can correlate a “threshold” flicker levelfor any particular patient (as measured above, using a slow and gradual“ramped” alteration of frequency or intensity levels) with the macularpigment density, for that patient.

Continuing the analysis mentioned above, Berendschot et al (1999 & 2000)indicated that the “spread” or “scatter” of the data that was generatedby flicker photometry indicated that their those measurements wereaccurate to a level of only about ±71% of the value indicated by ameasurement. This was less accurate than either SLO or reflectancemeasurements. However, it is believed that higher levels of accuracy andrepeatability can be achieved with more recent and improved machinesthat have been developed in the last 5-6 years since Berendschot et al(1999 & 2000) publications.

As one example, in the system developed by Snodderly et al, an optimalflicker frequency should be determined, for each patient using themachine. After that optimal frequency has been determined for aparticular patient, it is then used for subsequent testing of thatpatient.

In an alternate design created by Dr. Ian Murray et al, the intensity ofthe pulsating blue and green emissions is held constant, while thefrequency begins at a high rate and is gradually lowered. As soon as thepatient detects a flicker, he or she presses a button, which terminatesthe cycle and commences a new cycle, beginning once again at a highfrequency. By minimizing the amount of apparent flicker that the retinalneurons and the vision centers of the brain must process, this approachhelps minimize certain types of “neural adjustment and accommodation”mechanisms that the eye and brain normally use, which otherwise can leadto reduced accuracy, in subsequent “runs” that are done within a shorttime frame. This type of MPOD device 22 is discussed in a patentapplication in the United Kingdom, GB 0507430.7, which is incorporatedby reference in its entirety.

Autofluorescence Spectrometry.

Methods and machines also have been developed for carrying out atechnique that exploits another age-related factor. By the time a normalperson reaches the age of sixty, he or she will have accumulated somelevels of two types of cellular debris, called drusen and lipofuscin, inthe structural layers of the eye behind the retina. Those types ofdebris are well-known, and are discussed in detail in numerous articles.

One of those two types of debris, lipofuscin, is fluorescent. If excitedby light with blue wavelengths (which are absorbed by macular pigment),lipofuscin will fluoresce, which means it will emit light havingsubstantially longer wavelengths that are not absorbed by the macularpigment.

To exploit that fact, the MPOD device 22 using autofluorescencespectrometry (also called fundus autofluorescence) sends in a beam ofblue light into the eye. Depending on the density of the macularpigment, some portion of the blue light that enters the eye will beabsorbed by the macular pigment, and it will never reach any lipofuscindeposits that are located behind the retinal layer. The unabsorbedremainder of the blue light beam will pass through the macular pigmentand the retinal layer, and it will reach the structural layer behind theretina. That unabsorbed blue light which reaches the structural layerswill cause the lipofuscin deposits begin fluorescing, which causes themto emit light at a substantially longer wavelength. Fluorescing lightthat is emitted by the lipofuscin will not be absorbed by the macularpigment; therefore, some portion of that fluorescing light will travelback out of the eye, where it will reach a camera or photodetector thatmeasures its intensity.

Therefore, if a person has a high level of macular pigment, most of theblue light will be absorbed before it can reach the lipofuscin, and thelevels of fluorescent emissions by the lipofuscin deposits will be low.By contrast, if a person has a low level of macular pigment, more bluelight will reach the lipofuscin, and the levels of fluorescent emissionsby the lipofuscin will be higher. This enables the levels of macularpigment to be measured. These types of autofluorescence measurements arediscussed in articles such as Delori et al 2001 and “Fundusautofluorescence imaging compared with different confocal scanning laserophthalmoscopes” Bellmann et al (2003), which are hereby incorporated byreference in their entireties.

Raman Scattering.

Another method of measuring MPOD relies on a phenomenon known as “Ramanscattering” of light, described in “Resonance Raman Measurement ofMacular Carotenoids in the Living Human Eye,” Bernstein et al 1998. Afull description of Raman scattering is beyond the scope of thisapplication, and is not essential for an understanding of thisinvention. However, a brief overview can help readers understand it, ifthey choose to dig deeper.

Nearly any complex molecule that has multiple bonds (especiallyunsaturated bonds) can cause some degree of Raman scattering. While itis a weak phenomenon, it can be measured by sufficiently powerful orprecise instruments, or under conditions of relatively strongexcitation. Therefore, measuring the exact patterns of the shifts inwavelengths, caused by Raman scattering of a particular known lightsource by some particular gaseous or liquid mixture, can provide usefulclues about what is in the mixture.

Since zeaxanthin and lutein (the two macular pigments) are complexmolecules with multiple double bonds, they each cause their owncharacteristic types of Raman scattering, with slightly shiftedwavelengths. Those characteristic scattering patterns can be used todetermine the concentrations of zeaxanthin and lutein, in human maculas.

Since Raman scattering is a fairly weak phenomenon, a powerful lightmust be shone directly into the eye. Early tests suggested that thelight may be uncomfortably bright for patients. However, using some typeof Raman scattering MPOD device 22 may be possible as development ofthis type of technology continues.

Modified Fundas Camera and the Anomalscope.

The modified fundas camera utilizes multiple wavelengths and filters tomeasure the macular pigment density. An anomalscope may also be used tomeasure macular pigment density.

Referring now to FIG. 3, the computer 20 is schematically illustrated inmore detail. The computer 20 includes a processor 30 for executing thevarious instructions related to the overall functions of the computer20. The processor 30 is coupled to a local storage device 32, a display34, and a user interface 36. The local storage device 32 (one memorydevice or several memory devices) stores the various instructions thatallows the computer 20 to interact with the MPOD device 22, to interactwith the host 12, and to receive inputs and provide outputs to anindividual operating the computer 20. Although the display 34 is shownas been a part of the computer 20, it should be understood that thedisplay 34 can be one of many types of output devices such as CRTscreens, flat screens, plasma screens, etc. fr that are coupled to theprocessor 30. The user interface 36 can be in the form of a keyboard, avoice recognition system, a touch screen overlying the display 34,and/or other types of input devices allowing the user to enterinformation to the computer 20.

The user interface 36 may also receive information a biometric readingdevice for recognizing a distinguishable physical attribute of a patientso as to identify the operator for providing access to the computer 20.The biometric reading device may be contacted by the hand of theoperator to read the geometry of the hand or the fingerprints on one ormore of the fingers. After the biometric reading device scans theinformation, the processor 30 (or a remote processor at the host 12)performs a comparison to determine the identification of the operator atthe computer 20. Additional information regarding fingerprint scanningor hand geometry scanning is available from International BiometricGroup LLC of New York, N.Y.

Other biometric identification devices can be used and coupled to theoperator interface 36. For example, a microphone can be used as thebiometric identification device so that a operator can be recognizedusing a voice recognition system. In such a system, a patient claims anidentity, which is recorded, and his or her voice-print is matched to avoice-print on file to verify the operator's identity. Further, thecomputer 20 may include a biometric identification device that scans theretina or the iris for identifying the patient. Additional informationregarding iris or retinal scanning is available from InternationalBiometric Group LLC of New York, N.Y. The MPOD device 22 may alsoincorporate a retinal scanner for identifying the patient.

The computer 20 includes an input-output interface 38 allowing thecomputer to be coupled to the host 12. Similarly, the computer 20 alsoincludes an input output interface 40 allowing the computer 20 to becoupled to the MPOD device 22.

In one preferred embodiment, the computer 20 is a conventional desktopor laptop computer, as already found in nearly in place of business,which has been modified by loading software into it that will alsopermit that computer to function as a unit within the system 10. In someregards, the MPOD device 22 that measures macular pigment may beconsidered a “computer peripheral” that interacts with the computer 22in an office of the front line eye specialists. The input-outputinterface 40 is preferably a USB port (USB-1 or USB-2 interfaces), whichis ideally suited to provide this type of interface to a peripheraldevice. The USB system has been adopted worldwide, and most moderncomputers are sold with at least two, frequently three, and often fourUSB slots. In addition, small and inexpensive external routers or hubscan be plugged into any USB slot, to convert that slot into multipleadditional USB slots. Nevertheless, it should be recognized that otherdata transfer protocols are available, and can be used if desired. Suchdata transfer interfaces that can be used with the input-outputinterface 40 of the computer 20 include the “Firewire” (also called theIEEE 1394 standard), wireless systems such as “WiFi” and “Bluetooth”,and other communication protocols (such as the X10 system) that transmitdata signals that are “layered” on top of alternating current powersupplies.

The input-output interface (or interfaces) 40 enables the computer 20 tointeract and exchange data and/or commands with one or more types ofexternal devices that can be plugged into the computer 20, via a cableor similar interface, as described below. In home and office use,computer peripherals include printers, digital cameras, video cameras,joysticks or other controls for games, audio equipment such asmicrophones, telephones, musical devices, etc. In laboratories, mosttypes of analytical devices (often called “instruments”) such aschromatographs, spectrometers, photodetectors, etc., have been adaptedto convert any measurements into digital signals that can be sent to acomputer. Such devices usually contain at least one microprocessor(i.e., an integrated circuit that has been loaded with software codethat allows the device to be activated and controlled by commands from acomputer). In one basic type of system architecture, the processor 30within the computer 20 is considered the “master” while the processorwithin the MPOD device 22 is considered the “slave” that performs thefunctions dictated by the processor 30.

Software that allows for the functioning of data transfer between MPODdevice 22 and the computer 20 is located within the MPOD device 22 andthe computer 20. In other words, the MPOD 22 includes software allowingit to operate so as to take measurements from the patient and softwarethat provides for communication of the data to the computer 20. And, thesoftware in the computer 20 allows it to receive information from thepatient via the user interface 36, receive data from the MPOD device 22,and store that data in the local storage device 32 in a file associatedwith the patient. As discussed below, the patient-specific data filesare preferably transferred on a periodic basis to the host 12 forstorage in the host storage device 14. The software for the computer 20is written for a particular type of operating system that runs thecomputer 20. Because of the dominance of “WINDOWS XP” (trademark ofMicrosoft Corporation) and other “WINDOWS” varieties as the operatingsystem for computers 20 used in offices of the front line eyespecialists, any software written for the computer 20 is oftencompatible with most existing systems such as the WINDOWS XP system. Ifdesired, the software also can be “ported over” to other systems, suchas computers that are running Linux and/or MacIntosh software.Accordingly, skilled programmers who specialize in writing software forcomputerized peripherals that interact with computers are readilyavailable and can create software packages that allow the MPOD device 22and the computer 20 to interact.

As mentioned above, the computer 20 in the front-line eye specialistoffice must have the input-output interface 38 to allow the computer 20to transfer data to the host 12 that will compile data from numerousoffices. The input-output interface 38 can be provided most convenientlyby using the Internet. This can be done via either (i) a conventionalmodem, which allows data to be sent or received via a conventionaltelephone connection, or (ii) “Ethernet” ports and cables, which allowhigh speed (often called “broadband”) data transfers. Both types ofhardware interfaces are well known, and are contained in nearly alldesktop, laptop, or notebook computers. Software for allowing such datatransfers is also well known, and includes Internet browser programs(e.g., Microsoft's Internet Explorer, Mozilla's Firefox, and the AmericaOnline system), e-mail software that allow files to be sent asattachments (e.g., Outlook, Eudora, and AOL), and stripped-down systemsthat have few graphical interface requirements, such as “ftp” (filetransfer protocol) software that can be run in Windows, Linux, DOS, andother systems.

As will be recognized by those skilled in the art, convenient andautomated data transfers that do not require any individual attention(unless a malfunction occurs) can be made within the system 10 from thecomputers 20 a-20 n (FIG. 2) to the host 12 by means of an Internetwebsite. An entire website can be dedicated to that purpose;alternately, one or more web “pages” or options can provide thatfunction as part of a larger website. The coding that is required tocreate that type of website functionality is well within the skill inthe art among specialists who design and create web pages, and dozens ofdifferent software packages are available for that type of coding(Microsoft's FRONTPAGE and Macromedia's DREAMWEAVER are two examples ofsoftware packages that help programmers create websites that caninteract with other computers).

The host 12 has the desired functionality for receiving, storing, andprocessing thousands of data files that will be sent to it, presumablyon a weekly, monthly, or quarterly basis, from hundreds or thousands ofdifferent computers 20. The host 12 can be considered a so-called“server” that has enough storage with the storage device 14 (one deviceor several storage devices) to function as a “holding tank” for thedata, until the data is processed and handled in an appropriate manner.Such processing will include, for example, periodic creation of backupand/or transfer copies of the data, using storage systems such asportable storage medium (e.g. CDs).

File transfers from the computer 20 to the host 12 can be done by usingautomated routines that are comparable to sending an email with anattached file to a recipient. The computer 20 can be programmed toautomatically send the data at any convenient time (such as, forexample, once per week, every Tuesday morning, or once per month, on thesecond Tuesday of the month, as soon as the computer is turned on thatmorning). Designated target transfer times can be assigned anddistributed among different participating computers 20 a to 20 n, tocreate relatively steady levels of transfers throughout a week or month,rather than having thousands of transfers at the same time. The computer20 can be assigned to overnight hours with low traffic levels, such asbetween midnight and 6 am. If desired, more than one “server” at thehost 12 can be used, and such servers within the host 12 can be locatedin different parts of the globe, such as one in Asia, one in Europe, andone in North America.

Each file transferred by the computer 20 can be given a coded filenamethat will make it easy to clearly identify the sources and dates of allsuch files that are received by the host 12. This can be doneautomatically by the software that runs on the computer 20. For example,the first “field” in each filename can contain 4 to 8 letters or digits,which will identify the specific computer 20 that sent the file. Anarbitrary punctuation mark can be inserted next, to separate the firstand second fields, and to ensure that only properly-named files will besent to the standard folder or directory that receives those particularfiles, while any other files are sent to other folders or directories onthe server. The next 6 to 8 digits can indicate the opening date of afile (such as using a DDMMYY sequence, where D, M, and Y are variablesthat correspond to a specific day, month, and year). Another arbitrarypunctuation mark can set off the next field in the filename, and thelast 6 to 8 digits can indicate the closing date of the file.

Other and/or additional file naming protocols can be used if desired.For example, a confirmatory digit can be added to the end of thefilename, which will calculated by the computer as it creates the filename, in a way that causes the sum of all of the digits in the filenameto add up to an arbitrary number (such as a multiple of ten, which mustend in a zero). This type of system, to create a checking and confirmingmechanism, is widely used in barcodes, ISBN numbers for books, etc.

While these types of file transfers can be automated and made simplerand more convenient by using websites and Internet resources, alternateand/or additional file transfer and data collection options can beprovided and used, if desired. As one example, various types ofcomputerized “polling” routines and options can be used. In one set ofoptions, the host 12 can be programmed to directly and securely contacteach computer 20 in a list of computers, either on a regular periodicbasis, or if a scheduled file transfer has been missed by more than afixed period of time (such as more than two days, a week, etc.). Inanother set of options, if a file transfer has not occurred within acertain period of time, a window can open automatically on the display34 of the computer 20, stating that a file transfer needs to be madesoon, and asking the operator for instructions to either activate a filetransfer at that time, or to provide another reminder at some time inthe future (such as an hour, day, or week later). These types ofroutines are used by various companies that handle business over theInternet, such as (for example) companies that provide anti-virussoftware for computers (e.g., McAfee™ Security), which must be updatedregularly in order to remain effective. Such methods can be adapted foreither of two classes of use: (i) to supplement regular and scheduledfile transmissions to an Internet website; or, (ii) as part of a programthat requires individual “polling contacts” to be established directlybetween two computers.

FIGS. 4-11 will now be described in more detail. Each of these figuresrelates to information that can be illustrated on the display 34 of thecomputer 20 within each module 18. As will be seen in the discussionbelow, the display 34 is useful for the patient who is having his or hermacular pigment tested and the operator of the module 18 (e.g., anoptometrist) who uses the computer 20 to learn more about a specificpatient or results provided by the host 12 as to what nutritionalsupplements could be beneficial to his or her patients.

FIG. 4 illustrates an exemplary screen on the display 34 of the computer20 for a new patient who is taking the macular pigment test for thefirst time. The computer 20 is requesting that the patient enter variousbits of patient information 50 through the user interface 36 associatedwith a computer 20. The patient may enter this patient information 50through a keyboard or touch screen overlying and associated with thedisplay 34. The display 34 may also include a date field 52, with thedate being entered by clock associated with the computer 20.

It must also be noted that the computer 20 may provide automatedinstructions that can help guide users through complex processes, orsequences of multiple steps. For example, digitized voice instructionsas an output to the patient can be provided by a small and inexpensivespeaker that can play a pre-programmed sequence of audio files (e.g. mp3files that can be stored in the local storage device 32). Other types ofcomputer files, in formats that have filename extensions such as .mov,.avi, or .vob (these and other video file types are familiar to thosewho work with computerized video files) can be used to play videosegments that contain audio soundtracks. These files for assisting andinstructing the patient can be stored on at the local storage device 32of the computer 20. Alternatively, they can be stored in a peripheraldevice, or on a videotape, digital video disc (DVD), mini-disc, or anyother suitable storage media that can be played on an electronic player(for example, small and portable DVD players, with screens ranging fromabout 7 to about 10 inches diagonally and with built-in speakers, arewidely available at relatively low cost).

Within each patient's data file, the data will be organized into arraysof different “fields”. This will be comparable to a table that containscolumns and rows, with each row containing all of the relevant data froma specific customer or patient, and with each column assigned to containa certain particular type of data. For example, the patient enters datain the manner shown in FIG. 4 so as to provide some or all of thefollowing information for the patient's data file.

(1) a patient's identity, which can be identified by any of severalmeans (such as a patient's complete name if the patient has givenpermission, a patient's initials (which can be supplemented by thepatient's year or date of birth, to avoid potential conflicts), or anarbitrary coded number that is known only to the front-line eyespecialist;

(2) the patient's age;

(3) the patient's gender;

(4) the patient's eye color; (in three or four crude categories thatindicate blue, green, or brown, or one on a numerical scale that rangesfrom 01 to 99, which will be determined by using a color chart, withsevere to moderate albinism in the 01-09 range, pale blue colors in therange of about 10 to 25, up to very dark brown eye colors in the 90's);

(5) the patient's general health status, which can include known riskfactors such as diabetes, smoking, high blood pressure, etc.;

(6) the patient's responses to one or two brief questions asked abouthis or her diet, which will place the patient somewhere on a rough scalethat will generally indicate high levels of salad and green vegetableintake at one end of the scale, and high levels of sugary, salty, orgreasy snacks and fast foods at the other end of the scale;

(7) the types of drugs and/or nutritional supplements a patient wastaking when the first macular pigment measurement was made;

(8) the patient's general eye health, indicating factors such as mild orsevere far-sightedness, near-sightedness, or astigmatism, any problemsrelating to night vision, peripheral vision, color-blindness, glaucoma,etc., any presence of cataracts or lens implants, etc.;

(9) the patient's physical size, in weight and height, or body massindex;

(10) the patient's macular status, with any indicators of early-onset,middle-stage, or advanced problems in each eye, and also indicating anyknown family history, genetic analysis, or other indicators of variousknown eye disorders, such as Stargardt's disease, Best's disease,Batten's disease, Sjogren-Larsson syndrome, or macular degeneration;

(11) a patient's baseline (pre-treatment) levels of macular pigment, andalso indicating both (i) how the macular pigment density was measured,and (ii) the degree of confidence that the optometrist had in thatmeasurement, after witnessing the person who took the test;

(12) a coded number indicating whether the optometrist recommended thatthe patient should begin taking a nutritional supplement that containszeaxanthin, lutein, or a zeaxanthin-lutein mixture;

(13) a coded number indicating whether the optometrist recommended thatthe patient should begin taking any other nutritional supplements, suchas a general multi-vitamin supplement, an AREDS-type supplement withhigh dosages of anti-oxidants and/or zinc, etc.;

(14) a coded number indicating whether the patient purchased suchsupplements from the optometrist, or whether the patient purchased suchsupplements from any other source;

(15) any subsequently measured levels of macular pigment density, andthe dates of such measurements;

(16) any onset or progression of macular degeneration, after the firstmeasurement of macular pigment density.

Any or all of these data can be entered in the form of coded numbersthat are associated with certain answers that are likely to be receivedfrom the patient. These data can be gathered and compiled in any waythat is suited to the needs and working arrangements of a particularoffice. For example, some offices might prefer to have an optometristenter all of the data; other offices might prefer to have a receptionistor other assistant gather at least part of the data, either from a briefinterview with a customer, or from a worksheet that is filled out by acustomer before the customer sees the optometrist. Still other officesmight prefer to have at least some customers sit at the computer 20 anddirectly enter the appropriate information, which would then be reviewedand confirmed (and adjusted if necessary) by an assistant and/or theoptometrist.

The patient information gathered in FIG. 4 can also be supplemented byany additional measurements and/or data that optometrists choose togather that is helpful to his or her practice. Further, as the dataanalysis at the host 12 occurs over time, additional factual informationabout the patients may become relevant and the host interface 15 is usedto request that each module 18 begin to gather that new fact. Further,the host 12 may download a new version of the software to the computers20 that effectuates this change in collecting a new piece of factualinformation about the patients being tested at the modules 18.

In an alternative embodiment, items of the patient information areprovided with a score or grade to help determine the patient's riskassessment for acquiring AMD. The following Table provides examples ofthe scores or grades.

Factor Score age = 60-69 +1 age = 70-79 +2 age >80 +4 gender, if female+2 eye color, if light +2 body mass index >30 +3 smoking, if past smoker+2 smoking, if current smoker +5 family history of eye disease,cataracts +2 family history of eye disease, diabetic retinopathy +3family history of eye disease, parent with AMD +10 family history of eyedisease, sibling with AMD +5 current health history, cardiovascularproblems, +3 diabetics, or hypertension diet, 2 daily servings of darkgreen leafy vegetables −2 diet, 4 daily servings of dark green leafyvegetables −3 diet, 2 daily servings of yellow/orange vegetables −2diet, at least three weekly servings of cold water −2 fish, such assalmon, tuna, or sardines diet, daily intake of a multivitamin or anantioxidant −3 mixture extensive time in sun without adequate sunglasses+2 very sensitive to light +2

After the patient or front-line eye specialist has entered the patientdata, the computer 20 can quickly determine the patient's risk forbecoming inflicted with AMD. The risk assessment score is then availableto the patient and the front line eye specialist at the same time theMPOD test is being conducted. As an example, a risk assessment score ofgreater than X (e.g., +5) may automatically alert the front line eyespecialist to a need for a certain type of macular-pigment enhancingformula. If the MPOD result for that patient is below average, then therisk assessment score and the MPOD result should be an influential pieceof data that strongly suggests that the patient should be taking amacular-pigment enhancing formula, or preferably, a certain type ofmacular-pigment enhancing formula, which data within the system 10indicates has been beneficial for similarly situated patients.

Another beneficial aspect of the real-time data gathering and analysiswithin the system 10 is that certain factors in the Table above mayprove to be more important for predicting whether a patient may beinflicted with AMD. As an example, if the data gathered in the system 10indicates that there is a strong correlation between patients who arevery sensitive to light and diagnosis of AMD, the system 10 can send anupdated Table to each of the modules 18 a to 18 n, to replace the Tablelisted above. As such, the updated Table may reflect a score of +4 forthe category “very sensitive to light” instead of the +2 value listedabove. Each computer 20 within the system 10 is then automaticallyupdated for all future risk assessments of patients. The ability toprovide simplistic, real-time updates to each testing module 18 is oneof the primary benefits of the system 10.

FIG. 5 illustrates the display 34 on the computer 20 after the patienthas conducted the test on the MPOD device 22. In particular, the MPODresults 54 are shown to the patient along with information about what isan average, below average, low and good and MPOD test score. Additionalinformation may instruct the patient on the next step, which may includea consultation with a doctor associated with the MPOD module 18, such asan optometrist.

FIG. 6 illustrates the display 34 for the patient during a follow-upvisit to the module 18 and MPOD test. The patient is encouraged torepeat the tests over a period of time, especially if the patient had alow MPOD test result 54. The patient enters some type of patientidentifier (name, login name, anonymous input, etc.) via the userinterface 36 and the computer 20 is configured to illustrate on thedisplay 34 the previously entered patient information. The patient isasked to confirm the information that he or she has entered in theprevious visit. The patient may update the patient information 50, whichhas occurred here, in that the patient has now updated Question 10 toindicate the patient is now taking a daily eye vitamin. The date field52 is also updated to include the date of this subsequent test.

In one preferred embodiment, the patient information associated with thepatient is stored in the host storage device 14 and retrieved inresponse to the patient entering a patient identifier at the computer20. In this way, the patient is able to take the same type of MPOD testat several different locations and is able to retrieve his or herpatient information from any of the modules 18 connected to the host 12within the system 10. Alternatively, the patient information may besaved locally at the front line eye-health office, such as in thestorage device 32 of the computer 30 (assuming the patient visits thesame location). In other words, the patient information may be stored inthe local storage device 32 and that the host storage device 14. In thissituation, depending on the methodology for transferring data to thehost 12 from the modules 18, patient information can be updated orsupplemented at the time the patient information is polled (e.g.periodic polling) from the modules 18.

FIG. 7 illustrates the MPOD results for a second test. As shown, whencompared to the test results illustrated in FIG. 5, the patientexperienced an increased macular pigment density, which is beneficial.One likely cause for the increased macular pigment density is thesupplementation with the eye vitamin. While one aspect of the presentinvention concerns the overall system 10, it should be noted thatsupplementation with eye vitamins having a high content of zeaxanthinshould drastically increase macular pigment density and, therefore,lower the patient's likelihood for being inflicted with advancedage-related macular degeneration.

FIG. 8 illustrates a graphical form of historical data output for thepatient showing a significant increase in MPOD test results for thepatient over a period of time. Again, allowing the patient to see thehistorical results of the MPOD tests helps to illustrate and reinforcethe benefits achieved by altering some factor in the patient's life,such as supplementation with a certain type of eye vitamin. This type ofgraphical data shown on the display 34 of the computer 21 is alsohelpful for the front line eye specialist in understanding the past andcurrent conditions in the patient's macula. It should be noted thatFIGS. 7-8 are simply for illustration purposes as to how the display 34will work and does not reflect the MPOD results of a real person.

FIG. 9 illustrates a data input screen on the display 34 of thecomputer. This information may be displayed in response to a positiveanswer to the Question 10 in FIG. 4 or 6. In other words, if the patientindicates that he or she is taking an eye nutritional supplement, thenthe computer 20 may ask the patient which one of a variety of differenttypes of eye vitamins are being taken. This type of inquiry may also berequested by an operator of the module 18 after the patient hasindicated which nutritional supplement they are taking and the operatormay enter a coded data entry corresponding to that nutritionalsupplement. In short, due to the type of data being collected related tothe MPOD test results, it is preferred to learn about factualinformation about the patient's current eye vitamin supplementation.

FIGS. 10-11 illustrate the type of information that can be presentedbased on the patient information and MPOD data collected and analyzedfrom all of the modules 18 in the system 10. The host processor 13 alongwith an operator for guiding the host processor 13 via the hostinterface 15 (FIG. 1) develops various packets of useful informationthat are accessible to each of the modules 18. Considering the types ofinformation that are entered by each of the patients, analyzing the datafor certain population groups can be helpful for patients and thoseworking in the front line eye offices. The analysis information based onthe patient population derived at the host 12 can be periodicallytransmitted to the modules 18 (e.g., once a month, once a week, or oncea day), providing the patients and the front line eye specialists withsubstantially real-time updated information. Alternatively, or inaddition to the periodic transmission of analysis information, theanalysis information can be transmitted to a certain module 18 based onthe request of that certain module (e.g., upon the MPOD testing of apatient having certain characteristics associated with the patient'sinputted information, and the analysis information is directed to asub-group corresponding to those characteristics).

For example, as shown best in FIGS. 10-11, when a female patient in theage of 60 to 70 is having her macular pigment density checked for thefirst time, the patient and/or the operator of the module 18 can presentinformation like that shown in FIGS. 10-11 on the display 34 of thecomputer 20. This information may be helpful to the patient as she makeschoices about whether she should be taking some type of nutritionalsupplements. As such, this information can be presented to a patientafter the patient has undergone the tests via the MPOD device 22 tolearn that the patient's macular pigment density is low. Consequently,the present invention contemplates a methodology of (i) acquiringpatient information at the time of the MPOD tests, (ii) based on thetest results, retrieving information from the host 12 that isparticularly useful for a specific patient based on his or her patientinformation (e.g., age, sex, smoker, etc), and (iii) displaying thatinformation so that the patient can determine whether eye supplementshave been found to be helpful, or not helpful, for similarly situatedindividuals who have undergone the same type of testing. The methodfurther can be extended to displaying information pertaining to aparticular eye supplement to the patient so that he or she canunderstand more about a certain eye supplement was found to be helpfulfor similarly situated individuals Like the data in FIGS. 7-8, the datain FIGS. 10-11 is for illustration purposes and does not reflect actualdata that was gathered by the system 10

While FIGS. 10-11 show the results of some basic types of analysis ofthe data at the host 12, many types of analysis information can beperformed by the host 12 on the large scale data that is retrieved fromthe various modules 18. Here are two examples of some of the analysisconducted by the data-processing software 16 at the host 12.

Comparing Types Eye Supplements.

The data should allow a comparison of whether regimens of zeaxanthin,lutein, or zeaxanthin/lutein mixtures lead to comparable increases inmacular pigment densities, or whether zeaxanthin-only (orzeaxanthin/lutein) supplements lead to faster and/or larger increases inmacular pigment than lutein-only supplements. Such analyses can besubdivided, to analyze the general population while also analyzingspecific subgroups, such as people with early-stage maculardegeneration, abnormally low macular pigment, diabetes or diabeticretinopathy, a history of smoking or obesity, etc.

Comparing Dosage Levels.

The data should provide for correlations that establish links betweenany or all of: (1) dosage regimens of zeaxanthin, lutein, orzeaxanthin/lutein supplements, (2) blood serum levels of zeaxanthin orlutein, to the extent that blood tests are performed; and (3) detectablechanges in MPOD levels and any or all of: (a) stabilized or improvedvision clarity; (b) other indicators of stabilized or improved vision,such as improved dark adaptation, improved glare handling or recovery,improved peripheral vision, etc; (c) other indicators of stabilized orimproved retinal health, such as reduced progression of choroidalneovascularization or retinitis pigmentosis, improved recovery from eyeinjuries or infections, etc. The data should provide for otherindicators of stabilized or improved retinal health, such as reducedrates of cataract growth or surgery, etc.

The results, trends, and conclusions that become apparent after the datahave been gathered and analyzed by the system 10 will be highly usefulin helping various groups of people (including optometrists,ophthalmologists, and other physicians, as well as government agencies,insurance companies, people who suffer from macular degeneration,diabetes, or other medical problems, and friends, family members, andother caregivers who help take care of elderly people). The data shouldreach better levels of shared insights and consensus understandings,concerning best practices for treating macular degeneration at variousstages of severity and in various population groups, and for preventingit among the general population, especially among people who are knownto be at elevated risk of macular degeneration.

Such “best practices” for either prevention or treatment cannot be knownor predicted with certainty or reliability, prior to gathering andanalyzing the relevant and useful data. However, as can be made clear bycomparing the methods disclosed herein against the current plans for theAREDS-2 trial, the methods disclosed herein will create and provide abetter method for gathering truly useful, helpful, and reliable datethat will allow direct comparison of zeaxanthin against lutein, andagainst zeaxanthin-lutein mixtures. Zeaxanthin-lutein mixtures that arelikely to be tested include (i) 5:1 ratios (i.e., lutein to zeaxanthin),as initially chosen by the people planning the AREDS-2 trial, to emulatethe relative concentrations of those two compounds in circulating blood;or, (ii) 1:1 ratios (also called 50:50 ratios) which can roughly emulateretinal concentrations, and which can provide good mid-points in curvesthat will be generated from the data.

The design and conduct of the tests disclosed herein, and the creation,gathering, analysis, and reporting of the resulting data, are intendedto be unbiased, in ways that will allow and encourage fair, direct, andrevealing comparisons of zeaxanthin against lutein, and againstzeaxanthin-lutein mixtures.

The Business Method of this Invention

As mentioned above, the distributed computer system 10 of the presentinvention also enables the creation and implementation of a businessmethod that is regarded as an integral part of this invention. The basicbusiness method generally involves the following five steps:

(1) Placing multiple MPOD devices 22 that are designed and equipped (andwhich already contain software that will allow them) to interactdirectly with the computers 20 that are already found in offices offront-line eye specialists;

(2) Providing front-line eye specialists' with software that can beconveniently loaded onto their computers 20, which will allow computers20 running such software to: (i) directly interact with and receive datafrom the MPOD devices 22; (ii) store and organize such data in properlyformatted data files that contain relevant patient information, macularpigment data, other ocular and health data, and information on anyzeaxanthin and/or lutein supplements that are actually purchased andused by such patients; and, (iii) periodically provide for the transferof data files to a designated website or data-compiling computerassociated with the host 12;

(3) Compiling and organizing the data files from the computers 20 atnumerous different offices, into a coordinated compiled database at thehost 12 that will allow analysis of the macular pigment data in waysthat allow such data to be evaluated with respect to differentpopulation and subpopulation variables;

(4) Analyzing the compiled macular pigment data, to evaluate trends andreach scientifically-supported conclusions concerning the efficacy ofeye supplements, and in particular, zeaxanthin and/or lutein supplementsin preventing or treating macular degeneration;

(5) Transferring such compiled trends and related information (includinginformation on trends and scientific conclusions concerning the efficacyof supplements for preventing or treating macular degeneration)available to the front-line eye specialists in ways that will helppatients and front-line eye specialists to make intelligent andreasonable decisions that can help them avoid or treat maculardegeneration.

The business method outlined above can be enhanced by also carrying outone or more of certain optional steps, as follows:

(1) Using the compiled scientifically-supported trends and relatedinformation to issue, publish, and publicize a set of “best practice”recommendations for eye supplementation, in ways that can be subdividedand adjusted as appropriate for various classes or subgroups of patients(such as, for example, patients who can be assessed and placed into oneof the following four categories: (a) patients with apparently good eyehealth; (b) patients with diabetes and/or early indicators of maculardegeneration; (c) patients with moderate-stage macular degeneration; or,(d) patients with advanced macular degeneration).

(2) Continuing to gather data from front-line eye specialists in thesystem 10, and using such data to continue to study any trends that areshown by the data, among different population groups, thereby creating afeedback loop that will lead to ongoing refinements and improvements inthe “best practice” recommendations for various population groups.

(3) Periodically or intermittently publishing and publicizing anyupdates or adjustments to the “best practice” recommendations,preferably with assistance and support from government agencies, publichealth officials, consumer advocates, and not-for-profit organizationsthat work to help prevent or treat blindness; and

(4) Providing, at the front-line eye specialist, a plurality of eyesupplements that are provided to patients based on certain conditions.As an example, the patient is provided with a recommendation for a firstdaily dosage of zeaxanthin (or another type of macular pigment enhancingformula) to increase macular pigment to a desirable level over a periodof time in response to having an undesirable macular pigment level. Inthe alternative, the patient is provided with a recommendation for asecond daily dosage of zeaxanthin (or a second type of macular pigmentenhancing formula) that is less than the first daily dosage time inresponse to having a more desirable macular pigment level. Suchrecommendations and sales can help ensure that health carerecommendations from a skilled professional are actually followed bycustomers (especially elderly customers, who may be forgetful, or whomay not be able to take all of the various steps that might be necessaryto order something over the Internet or through similar channels).On-the-spot sale and delivery of nutritional supplements directly intothe hands of a person who is suffering from a vision problem, and whoneeds such supplements in order to prevent serious worsening of his orher vision problem, is especially helpful, important, and proper.

FIG. 12 provides a schematic of one embodiment of the overall businessmethod 100 according to the present invention. The method 100 includesthe initial eye exam on the MPOD device 22 (S102) and the entry andgathering of patient information at the computer 20 (S104). The patientis then provided with some type of report and/or a risk assessment basedon the results of the MPOD test and information that was gathered(S106).

Next, the patient purchases a supply of a certain nutritional supplementfor the eye based on the patient's information and test results.Preferably, the sale occurs directly at the offices of the front lineeye specialist (S108). The information concerning the nutritionalsupplement that was purchased by the patient is also recorded in thecomputer 20.

The relevant data related to the patient is also transferred to the host12 (S110). The relevant data from the patient is stored within thestorage device 14 associated with the host 12 (S112) and can be analyzedfor scientific purposes and long-term studies (S114). The data for thatpatient and information related to be data analysis and long-termstudies can then be transferred back to the front-line office computer20, as needed. (S116). One example of the type of information that canbe provided to the patient and/or front line eye specialist is theinformation illustrated in and described with respect to FIGS. 10-11.

Additionally, information related to the patient (e.g. contactinformation, date of previous MPOD high exam, nutritional supplementthat was purchased, and possibly and MPOD results) is provided to themarketer of the recommended nutritional supplement. (S122). The transferof this information allows the marketer to be interactive with thepatient by providing them information concerning (i) the need for apossible follow-up exam, (ii) purchasing additional quantities of acertain nutritional supplement, and/or (iii) results from the long-termstudies that may be helpful to the patient. Based on this patientinteraction (S124), the patient may return to the same office or adifferent office to have a follow-up eye exam (S126). The patient mayalso request the office to provide another supply of additionalnutritional supplements (S108). Or alternatively, and preferably, thepatient may order the nutritional supplement directly from the marketerof that specific nutritional supplement. (S130). It should also be notedthat the marketer may be provided with information from the officecomputer 20 about additional purchases from a patient (or patients) andsend a communication to the office (i.e. the module 18) about the needto replenish inventory of a certain nutritional supplement. Hence, thatis the purpose of the additional double-arrow connecting boxes S120 andS108.

Further, if the marketer of the nutritional supplement knows the amountthat was purchased, the marketer can provide well-timed communicationsto the patient. The communications to patients can include discounts onthe next purchase or partially reimbursing the patient for the next MPODtest if additional nutritional supplements are purchased.

Similarly, it is presumed that most patients will readily agree toparticipate in the data-gathering project disclosed herein, out of adesire and motivation to help reduce blindness. However, if deemednecessary and appropriate, such customers might also be provided withsome type of product discount or other incentive for an eye supplement,in exchange for agreeing to allow their data to be compiled in a largerdata-gathering effort at host 12.

If desired, other additional and optional steps to expand the usage ofthe system 10 can be added to the business method. For example, the MPODdevices 22 for measuring macular pigment can be enhanced to provide themwith instructional guides and aids (such as small speakers that willplay prerecorded voice instructions, a video-type presentation that canbe provided separately or that can be played on the same screen thatwill be used for other visual displays inside the measuring device,etc.) that will enable reasonably accurate and useful macular pigmentmeasurements to be made in locations such as drugstores, physician'swaiting rooms, tables or booths that can be set up in shopping malls orother high-traffic areas, etc. In general, these types of installationswill not be as well-suited for gathering statistically reliable data asinstallations that are supervised and run by trained personnel in alocation such as an optometrist's office. However, these types ofinstallations (i.e. less supervised modules 18) can be very useful inincreasing awareness among the public of the importance of goodnutrition (and, if needed, good nutritional supplements) for eye andvision health.

Thus, there has been shown and described a new and useful multi-partcomputerized system that will enable provide major advances inpreventing and treating macular degeneration and possibly other eyediseases, and a business method that will help front-line eyespecialists, such as optometrists and ophthalmologists, better servetheir customers and patients, while also helping and benefiting thepublic interest. Although this invention has been exemplified forpurposes of illustration and description by reference to certainspecific embodiments, it will be apparent to those skilled in the artthat various modifications, alterations, and equivalents of theillustrated examples are possible. Any such changes which derivedirectly from the teachings herein, and which do not depart from thespirit and scope of the invention, are deemed to be covered by thisinvention.

Linking Others to the System 10.

The host 12 can be further linked to other computers associated withindividuals who may be interested in the data being collected. Forexample, the host 12 could be linked to the executive directors and/orthe scientific or research directors of several not-for-profitorganizations that work with eye and vision research, such as theFoundation for Fighting Blindness, the Macular Degeneration Foundation,the Macular Degeneration Partnership, American Optometric Association,American Academy of Ophthalmology, and the American Academy ofOptometry, etc. Or the host 12 could be linked to researchers at medicalschools or eye care institutes who have worked in the past with thistype of research, including: (i) researchers who worked with theNational Eye Advisory Council, as listed in Vision Research—A NationalPlan: 1999-2003 Publ. 99-4120, 1999) and any subsequent updates of thatwork; (ii) researchers who worked with the steering committees thatguided the AREDS-1 study, as listed in Arch. Ophthalmol. 119: 1437-1438,2001); (iii) researchers who worked with the Eye Disease Case ControlStudy Group, as listed in Arch. Ophthalmol. 11: 104-109 (1993) and Arch.Ophthalmol. 10: 1701-1708 (1992); and, (iv) researchers who worked withthe Carotenoids in Age-Related Eye Disease Study (CAREDS), as listed inSnodderly et al 2004; or (v) researchers and officials at the NationalEye Institute, who are currently planning and arranging public fundingfor the AREDS-2 trial.

Checking for Other Eye Disorders at the Modules 18.

In at least some cases, an MPOD device 22 or the computer 20 can bedesigned and adapted to carry out additional types of measurements aswell. This is especially true when considering devices that use flickerphotometry to measure MPOD. Such devices provide both (i) an aperturewith a lens, which the user must look into, and (ii) a controllablelight-presenting display, inside the MPOD device 22. The types ofcontrollable light-presenting devices and displays that can be provided,in a device that is designed and suited for flicker photometry, can alsoprovide other displays that can enable measurements of, for example,dark adaptation, glare recovery, shape discrimination, etc. Similarly,the retinal damage that has been inflicted by glaucoma or various othereye diseases can be measured, and even mapped, by having a patientrespond to faint pinpoint-type light emissions that appear at variouslocations around the visual field, as the patient focuses on a specificpoint somewhere on a display screen. These measurements are sometimesreferred to as “Humphrey perimetry” measurements, made from instrumentsproduced by Humphrey Instruments, Incorporated of California.Light-emitting diodes or other electronic components that can enablethose types of measurements can be provided in flicker photometerdevices, and possibly in various other type of devices that can alsomeasure MPOD levels.

It should also be noted that numerous completely different types ofdevices and methods have been developed for measuring various eyeconditions, including some conditions that can be affected by macularpigment levels. As examples, optometrists and ophthalmologists usevarious known devices and tests to measure factors such as: (1) howquickly a patient's eyes and vision can adapt to abrupt and majorchanges in light/dark conditions; (2) how well a patient's eyes andvision can handle glare conditions; (3) how accurately a patient candetect tiny or subtle differences in shapes, such as by comparingcircles that are nearly but not exactly circular; (4) how sensitivelyvarious parts of the retina can detect faint flickering lights thatappear in different locations within the visual field; and, (5)intra-ocular fluid pressures, which become crucially important inpatients with glaucoma. Those are just a few examples of the types ofdiagnostic tests that can be used to evaluate eye health, based onfactors other than the types of near-sightedness, far-sightedness, orastigmatic vision problems that are normally addressed by correctivelenses or laser surgery. The present invention contemplates the use ofother devices as peripherals to the computer 20 with the system 10 togather other data as well. As one example, the module 18 may include thecomputer 20, the MPOD device 22, and a secondary device for measuringthe fluid pressure in the eye. As another example, the module 18 mayinclude the computer 20, the MPOD device 22, and the computer 20 mayalso provide for an automated Amsler grid test.

While the illustrated embodiments have been described with regard to theMPOD testing, the present invention contemplates an eye healthmeasurement and storage system. The system comprises a plurality ofmacular-function measurement machines and a central host. The pluralityof macular-function measurement machines measure macular function inhumans (e.g., dark adaptation, shape discrimination, etc.). Each of themacular-function measuring machines includes a device for receivingmacular function data from a patient, at least one data transfer port,and at least one processor that enables the transfer of the macularfunction data from the transfer port. The central host is coupled to thetransfer ports on each of the plurality of computers. The central hostincludes a processor adapted to (i) store the patient data in a storagedevice and (ii) transmit macular-function study data to test locationsassociated with the plurality of macular-function measurement machines.

Further, while the MPOD device 22 and the computer 20 has been describedas being two separate devices, the present invention contemplates asingle MPOD device 22 having its own storage device device, user inputdevice, and display. The patient would enter patient information andview displayed information via the integral display on the MPOD device22. The MPOD device 22 could still be linked to a computer within theoffice, but for the purpose of transmitting information to that computerand the host 12. Or, the MPOD device 22 would include a wirelessnetworking card allowing it to be separately linked to a wireless router(e.g. a Linksys® Wireless 2.4 GHz Broadband Router) within the office.At periodic intervals, the MPOD device 22 would simply access theInternet via the wireless router and send the needed information to thehost 12. This is beneficial since the MPOD device is then free standing,only needing to plugged into a power outlet in the office.

Each of these embodiments and obvious variations thereof is contemplatedas falling within the spirit and scope of the claimed invention, whichis set forth in the following claims.

Many of the articles and publications on the attached list have beenreferenced above. Each of these articles is incorporated by reference inits entirety.

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Department of Physics, Florida International University, Miami 33199,USA Bone RA, Landrum J T. —bone@fiu.edu PubMed—Arch Biochem Biophys.2004 Oct. 15; 430(2):137-42—(1 page)

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1. An eye health measurement and storage system, comprising: a pluralityof macular-pigment measurement machines for measuring macular pigmentdensity in humans, each of said macular-pigment measuring machinesincluding a device for receiving macular pigment data from a patient, atleast one data transfer port, and at least one processor that enablesthe transfer of said macular pigment data from said transfer port; aplurality of computers each of which is associated with a correspondingone of said plurality of macular-pigment measuring machines, each ofsaid computers including a first port coupled to said data transfer portof said corresponding macular-pigment measurement machine for receivingsaid macular pigment data, each of said computers including a secondport for transferring patient data; and a central host coupled to saidsecond ports on each of said plurality of computers, said central hostincluding a storage device for storing said patient data. 2-74.(canceled)